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news.Abbott has received an approval from the FDA for two new dosage strengths of Simcor, a cholesterol medication. Simcor new dosage strengths are a combination of 40mg of simvastatin with either 500mg or 1,000mg of niacin extended-release.
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Abbott said that Simcor is a prescription medication used along with diet in people who cannot control their cholesterol levels by diet and exercise alone. Simcor is approved to raise HDL good cholesterol and lower levels of elevated total cholesterol, LDL bad cholesterol and triglycerides.
Simcor is a combination medicine used when treatment with simvastatin alone or niacin extended-release alone is not sufficient.
Eugene Sun, vice president of global pharmaceutical development at Abbott, said: “Approval of the new Simcor dosage strengths means that physicians and patients now have options to treat ipid disease.”
Abbott claimed that Simcor 500/20mg, 750/20mg and 1,000/20mg strengths have received FDA approval in February 2008.
Abbott stated that the FDA approval is based on the results from the Seacoast trial, which showed efficacy and safety of Simcor up to doses of 2,000mg niacin extended-release/40mg simvastatin daily in patients with mixed dyslipidemia and type II hyperlipidemia. The Simcor 40mg strengths are expected to be available in early August 2010.